Remedy Barrier Cream Cloths

Product NDC: 53329-074
11-digit product format: 533290074
Labeler code: 53329
Product ID: 53329-074_5693e3a7-6102-0b96-e063-6294a90ab48f
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CLOTH
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-08-31
Substance: DIMETHICONE
Active strength: 3.6 g/100mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Remedy Barrier Cream Cloths
Brand name suffix: Fragrance Free
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	3.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1534833	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00e0cd4a-6049-408a-ab3f-9edf97e6438a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-074-76	Remedy Barrier Cream ClothsFragrance Free	17 mL in 1 APPLICATOR	CLOTH	17		11
53329-074-76	Remedy Barrier Cream ClothsFragrance Free	8 in 1 PACKAGE	CLOTH	8		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
7-DEHYDROCHOLESTEROL	INACTIVE INGREDIENT	BK1IU07GKF	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
C12-20 ALKYL GLUCOSIDE	INACTIVE INGREDIENT	K67N5Z1RUA	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
C14-22 ALCOHOLS	INACTIVE INGREDIENT	B1K89384RJ	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CAMELLIA SINENSIS FLOWER	INACTIVE INGREDIENT	9I2BJY2J17	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CLOVE	INACTIVE INGREDIENT	K48IKT5321	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
COCONUT ALCOHOL	INACTIVE INGREDIENT	13F4MW8Y9K	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
DULSE	INACTIVE INGREDIENT	7832HOY4ZQ	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ETHYLENE BRASSYLATE	INACTIVE INGREDIENT	9A87HC7ROD	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)	INACTIVE INGREDIENT	86FQE96TZ4	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
METHYL DIHYDROJASMONATE (SYNTHETIC)	INACTIVE INGREDIENT	3GW44CIE3Y	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
OMEGA-3 FATTY ACIDS	INACTIVE INGREDIENT	71M78END5S	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SOY PROTEIN	INACTIVE INGREDIENT	R44IWB3RN5	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
UREA	INACTIVE INGREDIENT	8W8T17847W	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
VANILLA	INACTIVE INGREDIENT	Q74T35078H	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2
YEAST	INACTIVE INGREDIENT	3NY3SM6B8U	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-074	REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]	11	Current NDC, Legacy NDC, 2 package rows	20240120_00e0cd4a-6049-408a-ab3f-9edf97e6438a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 49 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Savvy Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE	Savvy Care and Cosmetics	05ee2662-6a51-6e49-e063-6294a90a4ed7	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Lavender Baby Petroleum	WHITE PETROLEUM	Home Smart Products	5828df37-2a42-4129-8e4e-d5ac9c4c9615	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	980d030a-feaf-4a81-865e-f85c66151380	2024-12-19	Warnings	Exact identifier application number: M016
Baby Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	caf568aa-3889-41ff-835e-875bb6d9ca79	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95	2024-12-19	Warnings	Exact identifier application number: M016
Cars Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	9905b5a4-382e-4d2a-b971-37998c14c330	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Aloe Vera Petroleum	WHITE PETROLEUM	Home Smart Products	2671f2ed-af9d-4234-95bf-def368242a78	2024-12-19	Warnings	Exact identifier application number: M016
DCH Scar	ALLANTOIN 0.5%	Derma Care Research Labs, LLC	00edbc64-9d32-5751-e063-6294a90a400b	2024-12-19	Warnings	Exact identifier application number: M016
Bamboobies Diaper Rash	ZINC OXIDE 15%	Derma Care Research Labs, LLC	0411f5e3-03d2-c512-e063-6394a90a37d3	2024-12-19	Warnings	Exact identifier application number: M016
Maximum Strength Medicated Foot Powder	MEDICATED FOOT POWDER	Jell Pharmaceuticals Pvt. Ltd.	cdaae985-5363-e9d2-e053-2995a90a2682	2024-12-18	Warnings	Exact identifier application number: M016
BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Jell Pharmaceuticals Pvt Ltd.	d80d21cf-9463-7184-e053-2995a90a23f3	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Baby Petroleum	WHITE PETROLEUM	Home Smart Products	edd9d018-c2c9-4a9a-b727-0a92cd463c02	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Cocoa Butter Petroleum	WHITE PETROLEUM	Home Smart Products	a65c8267-d34f-4542-a7ca-5180e860a03d	2024-12-18	Warnings	Exact identifier application number: M016
Princess Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	6d9c92bf-9263-40a4-acac-5c3f0b08c69d	2024-12-18	Warnings	Exact identifier application number: M016
Meijer Petroleum Jelly	WHITE PETROLATUM	Meijer Distribution, Inc	b299cf2a-2c6a-68f4-e053-2995a90a5bd7	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	29945734-4ea6-b702-e063-6294a90ae6f2	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Strategic Sourcing Services, LLC	29946912-9794-8a8e-e063-6394a90a279e	2024-12-18	Warnings	Exact identifier application number: M016
Caring Mills Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	fbbfa780-0e2b-1874-e053-6394a90a5eeb	2024-12-18	Warnings	Exact identifier application number: M016
Serawise Eczema Rescue	OATMEAL	DrAnaMaria.com LLC	e805866a-2349-4b86-bc83-a7c859cb9403	2024-12-18	Warnings	Exact identifier application number: M016
TheraCare Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	d6fad49b-8a49-7f7c-e053-2a95a90ae638	2024-12-18	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1534833	dimethicone 3.6 % Medicated Pad	PSN	00e0cd4a-6049-408a-ab3f-9edf97e6438a	11
1534833	dimethicone 36 MG/ML Medicated Pad	SCD	00e0cd4a-6049-408a-ab3f-9edf97e6438a	11
1534833	dimethicone 3.6 % Wipe	SY	00e0cd4a-6049-408a-ab3f-9edf97e6438a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-074-76	53329007476	8 APPLICATOR in 1 PACKAGE (53329-074-76) / 17 mL in 1 APPLICATOR	8 applicator	2016-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
074 078 Remedy Phytoplex Barrier Cream Cloths	Medline Industries, LP	2026-07-14	HUMAN OTC DRUG LABEL	12